NCT04506437

Brief Summary

This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

4.6 years

First QC Date

August 6, 2020

Last Update Submit

June 5, 2025

Conditions

Mental Health

Keywords

AdolescentFoster CareMental HealthNavigatorService Access

Outcome Measures

Primary Outcomes (3)

  • Time to treatment referral

    Number of days until treatment referral is made

    12 months post enrollment

  • Time to treatment initiation

    Number of days until attendance at first treatment session

    12 months post enrollment

  • Treatment engagement

    Engagement as measured by attendance in treatment for 6 or more weeks

    12 months post enrollment

Study Arms (2)

Family-based mental health navigation

EXPERIMENTAL

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Behavioral: Family-based mental health navigation

Standard of care, then family-based mental health navigation

ACTIVE COMPARATOR

During wait-list period receive standard of care engagement practices and services-as-usual, and after the wait-list period the participants receive the family-based navigator intervention combined with mHealth practices

Behavioral: Family-based mental health navigationBehavioral: Standard of care engagement practices

Interventions

Family-based mental health navigationBEHAVIORAL

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Family-based mental health navigationStandard of care, then family-based mental health navigation
Standard of care engagement practicesBEHAVIORAL

Standard of care engagement practices and services-as-usual

Standard of care, then family-based mental health navigation

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • English-speaking youth
  • Ages 12-17
  • Have an active dependency petition with the SF Unified Family Court (newly filed or existing when the trial starts)
  • Are open to SF DPH Foster Care Mental Health Clinic services
  • Have an involved caregiver/legal guardian for consent
  • Family has mobile phone access

You may not qualify if:

  • Youth is not English-speaking
  • Caregiver has impairment that would preclude providing informed consent
  • Unavailable guardian for consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94131, United States

Location

Related Publications (1)

  • Tolou-Shams M, Ramaiya M, Lara Salas J, Ezimora I, Shumway M, Duerr Berrick J, Aguilera A, Borsari B, Dauria E, Friedling N, Holmes C, Grandi A. A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 12;12:e49999. doi: 10.2196/49999.

    PMID: 37698896DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Marina Tolou-Shams, Ph.D

    UC San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a dynamic wait-listed design in which the investigators will test a theory-driven family-based navigator treatment engagement intervention (FCFN) while also collecting data on the FCFN model's potential implementation and adoption within child welfare and behavioral health settings.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

August 20, 2020

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)